In my compny fungal growth obsered in sterile area in every rainy season that problm create give me suggestion what i can do
why it is only in rainy season? that means either some leak / water dampness occurring within the facility or personnel and material flow. without knowing the facility design and process flow, I don’t think we can get any clarity. I know its difficult to share the design and facility. only other alternative is increasing the cleaning frequency by using sporicidal agents.
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Note that scientifically relative humidity above 65% can lead to mould growth
Please ensure that generally RH does not exceed that limit in clean areas particularly sterile areas
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Noted sir
Deviation to be initiated,
Media fill to be repeated.
Risk assessment to be carried out.
Proper CAPA to be taken.
Fumigation technique and disinfectant/ sanitization to be validated for seasonal variation in order to control the environmental excursion.
SOP practices to be reviewed.
Thanks
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Based PDA TR 70 and Critical point best practice recommendation and USP:
It is recommended to wipe (or mop) surfaces with “disinfectant with surfactant” (one step disinfectant cleaner) for daily cleaning and disinfection of sterile area , in addition to “weekly” wipe (or mop) surfaces with sporicidal agent (effective against bacterial & fungal spores) after applying the disinfectant with surfactant “or” weekly wipe (or mop) surfaces with one step disinfectant “sporicidal” cleaner (i. e. with surfactant)
Also based on Critical point best practice recommendation, MHRA , NHS, USP :
It is recommended to wipe surfaces of packaging intended to be introduced to sterile area with sporicidal cleaner (i.e. with surfactant) and allowed for its minimum contact time, to prevent the possibility of introducing spores (bacterial or fungal) into sterile area (Note: 40% of packaging to be introduced have “spores” on their surfaces)
Tnx sir
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Kindly Check the Hvac system and their Dusts where fungus growth obtained. may water exists in under or near the fan & Check the humidity also.
Generally GMP guidelines (WHO , EU (PIC/S) , FDA) and PDA require using “sterile” disinfectants and detergents inside Grade A , B areas
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